Intrathecal Pump Refills at Home

Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.

The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.

Study Overview

• Status: Completed
• Conditions: Telemedicine; Intrathecal Drug Delivery; Implantable Pump
• Intervention / Treatment: Procedure: Pump refill procedure at home

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient receives intrathecal drug therapy
• Patient is at least 18 years old
• Native French-or Dutch speaking persons.

Exclusion Criteria:

• Patients < 18 years old.
• No native Dutch or French speaking persons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refill at home; Patients will have one pump refill at home instead of at the hospital.	Procedure: Pump refill procedure at home; Implantable pump refill is performed at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Successful pump refill	A binary variable to indicate success or failure of this intervention, reported by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Patient safety	A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Physician safety	A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Environmental safety	An open question in which the physician can indicate whether there were any situations that were not safe.	Once, at the moment of the study visit, immediately after the pump refill
Clean, sterile procedure	An open question in which the physician can mention all potential risks.	Once, at the moment of the study visit, immediately after the pump refill
An objective confirmation of correct injection in the pump by ultrasound.	After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump.	Once, at the moment of the study visit, immediately after the pump refill
Adverse events	All adverse events will systematically be reported by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Patient feasibility	A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by teleconsultant	Quality of the internet connection will be evaluated by the teleconsultant.	Once, at the moment of the study visit, immediately after the pump refill
Time burden for teleconsultant	The time will be measured from the beginning until the end of the call.	Once, at the moment of the study visit, immediately after the pump refill
Physician feasibility	A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.	Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by physician	Quality of the internet connection will be evaluated by the physician.	Once, at the moment of the study visit, immediately after the pump refill
Time burden for physician	The time will be measured from the beginning until the end of the call.	Once, at the moment of the study visit, immediately after the pump refill
Patient preference	Patients will be asked to indicate whether they prefer to have their next refill at home.	Once, at the moment of the study visit, immediately after the pump refill

Collaborators and Investigators

• Sponsor: Moens Maarten

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Escape

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No